Clinical trial related injury, deaths: Does the govt care?

Registering all clinical trials was made mandatory in 2005. But till today, there seems to be little clarity regarding exactly how many people have died or had to suffer serious adverse events due to the trials, how they have been compensated and how much was given to those who received any compensation at all. The issue of death or disability during clinical trials gets murkier as the Drug Controller General’s office provides more data regarding the trials and people adversely affected during the trials.

Instead of the data being publicly available on the website of the Central Drugs Standard Control Organization (CDSCO), it has been coming out in bits and pieces ever since rights activists and the media raised the issue of deaths during clinical trials that were not being compensated.

Going by the figure that the Health Minister submitted to Parliament a few months back, since 2007 till June 2012, there were 2374 deaths. In the latest affidavit filed in the Supreme Court by the Deputy Drug Controller General the total deaths of patients enrolled in clinical trials from January 2005 till June 2012 is 2,644, which is 270 deaths more. The only explanation seems to be that these 270 deaths took place during 2005 and 2006. Similarly, around 11,972 persons enrolled in clinical trials suffered serious adverse effects during the trials, but no year-wise break-up of this figure has been given.

What exactly would amount to a serious adverse event (SAE)? It is defined as anything that results in death or is life-threatening, requires hospitalization or prolongs existing hospitalisation, results in prolonged or significant disability/incapacity or congenital anomaly/birth defect. It is quite alarming that 21% or almost 12,000 of the total 57,303 people enrolled in the trial in 2005-12 suffered any of these serious events. However, the government affidavit states that only 506 of these SAEs, or roughly 1% and that just 80 of the total 2644 deaths, 3%, were related to clinical trials. It is not clear by what process the government has concluded that some of the deaths and SAEs were related to clinical trials while the bulk were not. Who conducted the enquiry to determine which deaths or SAEs were related to clinical trials? And no compensation seems to have been paid at all for any of the SAEs.

There is no provision under Drugs and Cosmetics Rule for financial compensation in case of clinical trial related injury or death of trial subject or parameters for assessing the amount of compensation. However, under Good Clinical Practice Guidelines for Clinical Trials formulated by the CDSCO such injury or death due to clinical trial is to be compensated by the sponsor of the trial. Till today, no formula for calculating compensation has been worked out by the government. Hence, even in cases where compensation was paid, the amount seems to have been decided by arbitrary methods by the companies.

Incidentally, the data submitted by the DCGI office is not their own. “This data is on the basis of the data provided by the firms which had conducted the clinical trials,” states the affidavit. The CDSCO is still “in the process of ascertaining the status of such cases pertaining to the years 2005 onwards”. The data of compensation paid is provided only from 2008 till 2011. This again goes to show that the CDSCO has not bothered till date to even find out whether deaths were ever compensated till the issue was highlighted by the media and taken up by the Apex Court. With such a lackluster approach from the agency supposed to regulate the trials, justice for people affected by clinical trials seems distant.

The affidavit stated that out of the 80 deaths said to be caused by the clinical trial, 41 have been compensated. However no details have been given such as when the compensation was paid and how much was paid? There is also no data on the age, gender, education, occupation and number of family members regarding each person who died because of the clinical trial. Dr C M Gulhati editor of Monthly Index of Medical Specialties (MIMS), pointed out that the data given by DCGI was a mixture, at some places referring to New Chemical Entities only while at others to all clinical trials such as compensation where old drugs have also been included. The Supreme Court rejected the affidavit and asked for one to be filed by the Union health secretary or the director general of CDSCO. Will the quality of data in the fresh affidavit be any better?

DISCLAIMER : Views expressed above are the author's own.

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Rema Nagarajan is with the Times Insight Group, which has a mandate to look at stories beyond and behind the headlines. She writes mostly on development issues like health and factors that affect people's quality of life. This includes life-affirming stories of extraordinary individuals and organisations who have made a difference.

Rema Nagarajan is with the Times Insight Group, which has a mandate to look at stories beyond and behind the headlines. She writes mostly on development iss. . .